Effects and Underlying Mechanism of Lipid Lowering Intervention on Vascular Protection in Hypertensive Patients

Hypertension Clinical Trial

Official title:

Effects and Underlying Mechanism of Lipid Lowering Intervention on Vascular Protection in Hypertensive Patients (EMINENT Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02254824
• Other study ID #: SF2011-4003-04
• Status: Recruiting
• Phase: Phase 4
• First received: April 17, 2014
• Last updated: September 29, 2014
• Start date: October 2013
• Est. completion date: October 2016

Study information

• Verified date: September 2014
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: Aimin - Dang, Doctor
• Phone: 0086-10-88398155
• Email: amdang[@]fuwaihospital.org
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of EMINENT study is to evaluate the efficacy of Xuezhikang or atorvastatin in hypertensive patients at low/moderate cardiovascular risk.

Description:

EMINENT study is to evaluate the efficacy of Xuezhikang or atorvastatin on vascular function protection in hypertensive patients at low/moderate cardiovascular risk.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: October 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• All patients must meet the hypertension with low or moderate cardiovascular risk following 2010 Guidelines for prevention and treatment of hypertension in China

Exclusion Criteria:

• Secondary Hypertension

• Women who are pregnant or lactating

• History of mental instability, or major psychiatric illness not adequately controlled and stable on therapy

• Type 2 Diabetes

• Active liver disease or impaired liver function tests

• Impaired renal function

• Uncontrolled cardiac arrhythmia

• Patient who is unable to give informed consent

• Any condition or situation, which in the opinion of the investigator, might pose a risk to the patient or confound the results of the study

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Xuezhikang
Xuezhikang
• Atorvastatin
Atorvastatin

Behavioral:
• Lifestyle modification
Lifestyle modification

Locations

Country	Name	City	State
China	Fuwai Hospital	Beijing	Beijing

Sponsors (4)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital	Beijing Hospital of Traditional Chinese Medicine, Peking Union Medical College Hospital, Peking University First Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint is the Flow Mediated Dilatation (FMD)		1 year	Yes
Secondary	the carotid - femoral Pulse Wave Velocity (cf-PWV),		1 year	Yes
Secondary	inflammatory markers		1 year	Yes
Secondary	lipid profiles		1 year	Yes